Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy

NCT00791440 | Completed

• 2 other identifiers: 5808K23MH077653
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the impact of Cognitive-Behavior Therapy (CBT) on symptoms, physiological arousal, stressors, and the ways to deal with them in individuals with schizophrenia and related disorders. The primary aim of this study is to investigate the role cognitive coping strategies play in mediating the link between stress, physiological arousal, and psychotic symptoms in individuals with schizophrenia during recovery from psychosis.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Schizophrenia; Schizoaffective; Schizophreniform; Psychosis; Psychotic; Hallucinations; Delusions; Paranoia; Paranoid; Voices; CBT; Cognitive Behavior Therapy; Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Scale for the Assessment of Positive Symptoms (SAPS)

  At Baseline and after 10, 20 and 30 weeks

Secondary Outcomes (3)

• Momentary self-report ratings of psychotic symptoms using a Palm computer

  At Baseline and after 30 weeks

• Momentary self-report ratings of stress and coping strategies using a Palm computer

  at Baseline and after 30 weeks

• Momentary ambulatory measures of heart rate and breathing

  At Baseline and after 30 weeks

Study Arms (2)

1

EXPERIMENTAL

Up to 26 sessions (over a 30 week period) of weekly, individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.

Behavioral: Cognitive-Behavior Therapy

2

ACTIVE COMPARATOR

30 weeks of standard psychiatric treatment.

Other: Standard Psychiatric Treatment

Interventions

Cognitive-Behavior Therapy BEHAVIORAL

Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.

Also known as: CBT for psychosis

1

Standard Psychiatric Treatment OTHER

Standard psychiatric treatment.

Also known as: Treatment As Usual (TAU)

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females between ages 18-50.
• Have capacity to give informed consent.
• English speaking.
• Have a DSM-IV diagnosis of schizophrenia, or schizoaffective disorder, or schizophreniform disorder.
• Presence of active psychosis as indexed by ratings ≥3 on any hallucinations and delusions items of the Scale for Assessment of Positive Symptoms (SAPS).

You may not qualify if:

• Lacks capacity to give informed consent.
• Diagnosis of mental retardation (IQ \< 80).
• Have history of neurological disorders or medical conditions known to seriously affect the brain.
• Have history of cardiac conditions or hypertension; current use of anti-cholinergic, beta-blockers, anti-histamine, or anti-hypertensive medication; abnormalities on ECG.
• Have used street drugs within the past 4 weeks.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University & New York State Psyciatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders; Hallucinations; Delusions; Paranoid Disorders

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David Kimhy, Ph.D.

  Columbia University & New York State Psyciatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

US (1)